Trial Outcomes & Findings for Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique. (NCT NCT00474968)

Results Overview

True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.

Recruitment status

COMPLETED

Target enrollment

737 participants

Primary outcome timeframe

At the time of cell collection.

Results posted on

2009-11-20

Participant Flow

Patients presenting for a previously scheduled colposcopy subsequent to an abnormal Pap result were recruited for this study.

Participant milestones

Participant milestones
Measure	SoftPAP Samples collected using the SoftPAP Collector	Brush/Spatula Samples collected using an endocervical brush and cervical spatula
Overall Study STARTED	366	371
Overall Study COMPLETED	348	355
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Reasons for withdrawal
Measure	SoftPAP Samples collected using the SoftPAP Collector	Brush/Spatula Samples collected using an endocervical brush and cervical spatula
Overall Study Withdrawal by Subject	8	7
Overall Study Protocol Violation	9	8
Overall Study Sample not collected	1	1

Baseline Characteristics

Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SoftPAP n=366 Participants Samples collected using the SoftPAP Collector	Brush/Spatula n=371 Participants Samples collected using an endocervical brush and cervical spatula	Total n=737 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	366 Participants n=5 Participants	365 Participants n=7 Participants	731 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	366 Participants n=5 Participants	371 Participants n=7 Participants	737 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	366 participants n=5 Participants	371 participants n=7 Participants	737 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of cell collection.

Population: 79/348 (Arm 1) and 81/355 (Arm 2) participants were excluded from the sensitivity/specificity analysis due to biopsy (Bx) and/or endocervical curettage (ECC) results not being reported

True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient.

Outcome measures

Outcome measures
Measure	SoftPAP n=348 Participants Samples collected using the SoftPAP Collector	Brush/Spatula n=355 Participants Samples collected using an endocervical brush and cervical spatula
Cell Collection Efficacy True Positive (TP) (Cytology Dx vs (Bx + ECC)	174 Participants	170 Participants
Cell Collection Efficacy True Negative (TN) (Cytology Dx vs (Bx + ECC))	33 Participants	14 Participants
Cell Collection Efficacy False Positive (FP) (Cytology Dx vs (Bx + ECC))	42 Participants	63 Participants
Cell Collection Efficacy False Negative (FN) (Cytology Dx vs (Bx + ECC))	20 Participants	27 Participants
Cell Collection Efficacy Excluded - Bx/ECC results not reported	79 Participants	81 Participants

PRIMARY outcome

Timeframe: At time of cell collection

Population: Includes all cytology specimens

Number and percentage of samples classified as adequate for diagnosis

Outcome measures

Outcome measures
Measure	SoftPAP n=348 Participants Samples collected using the SoftPAP Collector	Brush/Spatula n=355 Participants Samples collected using an endocervical brush and cervical spatula
Specimen Adequacy Satisfactory for Diagnosis	343 Participants	352 Participants
Specimen Adequacy Unsatisfactory for Diagnosis	4 Participants	2 Participants
Specimen Adequacy Excluded - Slide Preparation Error	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At the time of cell collection.

Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay

Outcome measures

Outcome measures
Measure	SoftPAP n=348 Participants Samples collected using the SoftPAP Collector	Brush/Spatula n=355 Participants Samples collected using an endocervical brush and cervical spatula
Human Papilloma Virus (HPV) Detection Frequency HPV Positive by Hybrid Capture-II	165 Participants	214 Participants
Human Papilloma Virus (HPV) Detection Frequency HPV Negative by Hybrid Capture-II	82 Participants	104 Participants
Human Papilloma Virus (HPV) Detection Frequency Hybrid Capture-II Results Not Reported	101 Participants	37 Participants

Adverse Events

SoftPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brush/Spatula

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Domanik, Ph.D.

CytoCore, Inc.

Phone: 312-222-9550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place